Mental Health Medical Devices: A Regulatory Overview
I have personally worked on some amazing devices in my time industry. From powered orthopedic implants to AI based cancer detection software.
Recently, an emerging area of medical devices that has been developing is devices used within the setting of mental health.
Typically, when we think of medical devices we think physical or physiological action taken to either improve or diagnose certain issues.
However, one area that is fairly unexplored is the area of mental health medical devices, these are also known as Digital Mental Health Technologies (DMHT). I think this definition could be expanded to “Mental Health Medical Devices” as some of these won’t be only digital.
We’re not going to niche into a particular area of regulation in this one, i.e., EU MDR, UK MDR or US QSR. We’re going to be pretty generalist here and look at a broad level some devices.
Some examples of DMHTs
Flow Neuroscience
Intended Purpose
Flow is a class IIa Medical Device intended for home-based treatments of adults (18+) diagnosed with Major Depressive Disorder (MDD).
Regulatory Status
On the EU market, CE marked by BSI.
Kintsugi
Intended Purpose (Perceived)
Using Artificial Intelligence (AI) to scan voice patterns (regardless of the phraseology) to analyse and identify signs of depression and anxiety.
Regulatory Status
Kintsugi is not a substitute for a clinician diagnosis and not to be used to make medical decisions outside of clinician supervision. Kintsugi is an investigational device not yet cleared by FDA for any particular use.
Oxehealth Vital Signs device
Intended Purpose
The Oxehealth Vital Signs device is intended for non-invasive spot measurement of pulse rate and breathing rate. It is a fixed-installation device for use within single occupancy rooms within hospitals, general care, domestic and secured environments where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.
The Oxehealth Vital Signs device is indicated for use on humans 12 years of age or older with all skin types, who do not require critical care.
Regulatory Status
Oxehealth Vital Signs software is a class IIa medical device in the UK and EU.
How do these devices fit into current regulatory frameworks?
I don’t want to point out the obvious here but I wanted to highlight some areas for consideration.
Firstly, this depends whether the device is considered a medical device or an in vitro diagnostic device. This will define it’s regulatory path upfront.
Furthermore, this will then become more specific if the device is broken down further into being Software as a Medical Device (SAMD) or Artificial Intelligence as a Medical Device (AIaMD).
Considerations of the Device as Potential Borderline
The first item is around ensuring that the device meets the definition of a Medical Device in line with the relevant regulatory requirements.
Many of these MHMDs may not truly constitute the definition of a device and instead be subject to general product regulations.
Regulation 2017 / 745 defines a medical device as:
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
devices for the control or support of conception;
products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Cybersecurity and Data Privacy
Most likely the primary area that will cause concern or scrutiny. These devices will contain huge amounts of extremely sensitive information from end-users / patients, which makes it key to consider cybersecurity, information security and data privacy given that this will be considered “health information”.
Risk Management
The type of risks with devices like these will be fairly unique and will require a comprehensive risk management framework that considers things such as aforementioned like cybersecurity.
In these sort of devices, reasonably foreseeable misuse becomes extremely broad and nees to ensure the correct level of expertise included in the risk management process.
Certain devices that fit this context could benefit from the input of clinical psychologists or counsellors throughout risk management process.
Clinical Evidence and Claims
If we take Regulation 2017/745 as the “most stringent” regulation, the proposed devices would have to be able to demonstrate clinical evidence of adequate performance in order to substantiate the device being placed on the market.
Manufacturers may only be able to make claims and promotional material that can be supported and substantiated.
Economic Operators
A specific area from Regulation 2017/745, but it is something worth considering. How is this device going to go from the manufacturer to being placed on the market to being made available up until the point of putting into service.
Final Notes and Competent Authority Action
Whilst this is an extremely new and emerging market, an MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies with input from patients, the public and mental health professionals.
The most recent update from the MHRA identified that future work packages will explore qualification and classification of DMHTs as SaMD, clinical evidence and post-market surveillance requirements and will seek to refine the findings and proposals to date into guidance.
It will be really good to see some harmonised guidance across the regulatory regions on this as I imagine these could end up being in a bit of a scenario like Borderline devices.
Anyway, that’s it. Thanks!
Adam